GI Symptoms with Vumerity Fewer and Milder Than Tecfidera, Phase 3 Trial Shows
Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared to Tecfidera (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these two relapsing-remitting multiple sclerosis (RRMS) treatments show.
These results were presented at the 27th Annual Meeting of the European Charcot Foundation, held in Baveno, Italy, on Nov. 21–23.
The EVOLVE-MS-2 trial (NCT03093324) evaluated the gastrointestinal tolerability, including the duration and severity of GI discomfort, of Vumerity 462 mg capsules to Tecfidera 240 mg capsules, both taken twice daily. Both Vumerity and Tecfidera, the most prescribed oral medication for RRMS, are marketed by Biogen.
The study, conducted in the U.S. and Europe, enrolled 506 RRMS patients and randomized them to either Vumerity or Tecfidera treatment for five weeks. Five key gastrointestinal symptoms were assessed.
Results showed that Vumerity’s use was associated with significantly less severe and shorter lasting gastrointestinal symptoms compared to Tecfidera, Biogen reported in a press release.
Participants assessed the duration and intensity of their symptoms using a new scale called the Individual Gastrointestinal Symptom and Impact Scale (IGISIS). This scale is self-reported, and ranks symptoms — like nausea, vomiting, upper and lower abdominal pain, and diarrhea — from 0 (no symptoms) to 10 (extreme symptoms).
Vumerity-treated patients compared to those given Tecfidera reported about 46% fewer days with IGISIS scores above or equal to 2.
The overall intensity of gastrointestinal symptoms and their impact on daily life activities was assessed using the Global Gastrointestinal Symptom and Impact Scale (GGISIS), also self-reported. Results showed that patients given Vumerity experienced a gradual decline in pain, seen in reported intensity scores, over the five weeks of treatment.
Therapy discontinuation due to gastrointestinal side effects was 0.8% among Vumerity patients and 4.8% among those in the Tecfidera group. The incident rate of investigator-reported gastrointestinal adverse effects was also lower in those treated with Vumerity (34.8%) compared to Tecfidera (49%).
Adverse reactions occurred in 78.3% of patients on Vumerity, and in 83.7% of those on Tecifedra. Most were said to be of mild or moderate severity.
Vumerity, developed by Alkermes in collaboration with Biogen, was approved by the U.S. Food and Drug Administration (FDA) in October to treat relapsing forms of MS, including clinically isolated syndrome (CIS), RRMS, and active secondary progressive disease (SPMS).
“We know that each patient’s journey can vary greatly in MS, so Biogen aims to meet individual treatment goals through our broad MS portfolio,” Alfred Sandrock, MD, PhD, an executive vice president and chief medical officer at Biogen, said in the release.
“Tecfidera is a clinically meaningful treatment for patients, and we believe Vumerity now builds upon our franchise as another compelling option for relapsing MS,” Sandrock added.